FDA 510(k) Application Details - K240303

Device Classification Name	More FDA Info for this Device
510(K) Number	K240303
Device Name	MetaLite DX Digital Pathology Software
Applicant	JelloX Biotech Inc. No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County 302041 TW Other 510(k) Applications for this Company
Contact	Fan Tzu-Han Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2024
Decision Date	10/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review